{"id":263,"date":"2024-06-29T17:40:16","date_gmt":"2024-06-29T17:40:16","guid":{"rendered":"https:\/\/helenaolbertova.com\/index.php\/home\/"},"modified":"2026-03-18T20:40:29","modified_gmt":"2026-03-18T18:40:29","slug":"home","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/","title":{"rendered":"Dom\u016f"},"content":{"rendered":"\n
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Independent IVDR Regulatory Consultant \u00b7 South Moravia, Czechia & Remote<\/p>\n\n\n\n

Helena Olbertova, Ph.D.<\/h1>\n\n\n\n

IVDR Compliance & EU Market Access
for IVD Manufacturers<\/h2>

65+ IVD products certified across all device classes (A\u2013D).<\/strong>
I turn complex IVDR regulations into swift EU market access \u2014 combining deep regulatory experience with smart, practical automation.<\/p><\/div>\n\n\n\n

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Book a Free 30-Minute Discovery Call<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n
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65+<\/strong>IVDR Certifications<\/span><\/p>\n<\/div>\n\n\n\n

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400+<\/strong>Legacy Devices<\/span><\/p>\n<\/div>\n\n\n\n

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6+<\/strong>Years Experience<\/span><\/p>\n<\/div>\n\n\n\n

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Ph.D.<\/strong>Oncology & Biology<\/span><\/p>\n<\/div>\n\n\n\n

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Classes A\u2013D<\/strong>All IVD Classes<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Services<\/p>\n\n\n\n

What I Can Do For You<\/h2>\n\n\n\n

IVDR is complex and unforgiving. Whether you are launching a new IVD, managing a legacy portfolio, or navigating a Notified Body review cycle, I bring hands-on expertise and proven documentation frameworks to move your project forward efficiently and with confidence. I work primarily with manufacturers and clinical laboratories operating within the European regulatory framework, or those approaching it seriously as a priority.<\/p>\n\n\n\n

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IVDR Certification Projects<\/h3>\n\n\n\n

Core service.<\/strong> I support the full certification journey for new IVD products and legacy device transitions, from the initial regulatory strategy through Notified Body submission and all the steps that follow once the certificate is issued.<\/p>\n\n\n\n